The U.S. Food and Drug Administration (FDA) granted emergency approval to Biontech/Pfizer's vaccine for children ages five to 11 on Friday (Oct. 29). FDA Acting Chief Janet Woodcock said after the decision, "As a mother and a physician, I know parents, child care providers, school staff and children have been waiting for today's approval." She emphasized that vaccinating younger children against Covid-19 is an important step back toward "some normalcy."Woodcock said the vaccine, developed by Mainz-based vaccine developer Biontech and U.S. pharmaceutical company Pfizer, met the FDA's "high standards." The drug agency's statement said, among other things, that the vaccine was safe and effective even in children younger than 12.
The FDA's Immunization Advisory Committee had recommended emergency approval for Biontech/Pfizer's vaccine for this age group on Tuesday (Oct. 26). The emergency approval was subsequently made official. Now, however, the Centers for Disease Control and Prevention (CDC) must make an appropriate vaccination recommendation before the age group can actually be vaccinated. A panel of experts there will consider the question of approval next week on Tuesday or Wednesday.
U.S. President Joe Biden had already announced that the vaccination campaign for five- to 11-year-olds would begin immediately following the release of a vaccination recommendation. About 28 million children between the ages of five and 11 live in the United States. The US government recently ordered an additional 50 million vaccine doses for children from Biontech and Pfizer.Current practice is for five- to 11-year-olds to receive two doses of the vaccine, each containing ten micrograms. The usual dosage otherwise includes 30 micrograms. According to statements by the Pfizer company, protection against Covid 19 disease from vaccination in five- to eleven-year-olds is 90.7 percent.
During the pandemic, children were found to be less affected by the coronavirus than older people, but the virus can be dangerous to them as well. In the U.S., 8300 children between the ages of five and 11 have been hospitalized for covid-19 illness since the pandemic began, according to the CDC. 146 children died from or with covid-19.
The Biontech/Pfizer vaccine had already received emergency approval in the U.S. for children twelve years and older and full approval for adolescents 16 years and older. In the EU, Biontech and Pfizer have also applied for approval of their vaccine for five- to eleven-year-olds. A decision in the EU is expected to be made by the European Medicines Agency (EMA) by Christmas.The chairman of the Standing Commission on Vaccination (Stiko), Thomas Mertens, had recently expressed reservations about Corona vaccinations for children as young as five. He argued, among other things, that the Covid 19 disease burden in the U.S. is "apparently higher than in Germany." He told the Dösselforfer Rheinische Post this week.